WHO offers some guidance on risky H5N1 studies

Jul 24, 2012 (CIDRAP News) – The World Health Organization (WHO) has offered some brief, general guidance on safety and security in research on laboratory-modified H5N1 viruses, mainly stressing that researchers should follow existing guidelines and gain authorization from their governments.

The one-page guidance document, posted recently on the WHO Web site, was prompted by the recent controversy over the publication of two studies involving lab-modified H5N1 viruses with increased transmissibility in ferrets, which raised concern about the risk of deliberate or accidental release of a virus that could spark a human flu pandemic.

The US National Science Advisory Board for Biosecurity (NSABB) recommended late last year that the details of those studies be deleted before publication. But after learning more about the studies, the board reversed its decision on Mar 30. The full studies were published in May and June, one in Nature and the other in Science.

The heated debate over the two studies prompted the WHO to hold a meeting of technical experts on H5N1 research issues in Geneva in February. Afterward, the new guidance document says, the agency consulted scientific groups and experts in human health and animal health for their views on lab biosafety and biosecurity precautions that should be used in further research on lab-modified H5N1 viruses.

The WHO also reviewed existing guidelines, such as those in the WHO Laboratory Biosafety Manual, 3rd Edition, the guidance says. The resulting guidance consists of six points:

Groups that want to work with lab-modified H5N1 "should critically evaluate the considerable personal and institutional responsibilities inherent in manipulating influenza viruses with pandemic potential that are not presently circulating in nature."

"Only laboratories that meet the appropriate biosafety level AND show conformity to available biorisk management standards (e.g. CWA 15793) should consider working with these laboratory-modified H5N1 strains, in close collaboration and communication with relevant national authorities, and under strict national oversight."

"Relevant national authorities should identify, approve and oversee the laboratories which might work on this material."

Lab biosafety and biosecurity should be considered in reviews of research findings scheduled for publication.

Individual governments and facilities have final responsibility for identifying and implementing appropriate risk assessment, mitigation, and containment measures for work with lab-modified H5N1 strains. Accordingly, measures may vary from country to country, and decisions should be made in light of available knowledge, context, and national requirements.

"Given the potential of these newly developed laboratory-modified H5N1 strains to start a pandemic, it is important that facilities that are NOT able to identify and appropriately control the risks associated with these agents REFRAIN from working with them."

The WHO guidance comes a few months after the US government issued a new policy on life-sciences dual-use research of concern (DURC)—studies that can be used for good or ill—in late March. In June, federal health officials promised that more details on the new policy, in the form of draft guidance for institutional biosafety committees, would be published soon in the Federal Register.

A publication date for the draft guidance has not yet been determined, Nalini Padmanabhan, MPH, a spokesperson for the National Institute of Allergy and Infectious Diseases (NIAID), told CIDRAP News today.

While researchers wait for more details on DURC policy, a voluntary moratorium on studies involving lab-modified H5N1 viruses is continuing. Leading flu researchers announced the moratorium in January, amid the controversy over the two studies involving ferret-transmissible H5N1 viruses.

At a press briefing in June, NIAID Director Anthony Fauci, MD, said possible pathways toward lifting the research moratorium would be discussed at the upcoming meeting of the agency's Centers of Excellence for Influenza Research and Surveillance (CEIRS). The meeting is scheduled for next week in New York City.

The CEIRS network consists of five academic centers that conduct a wide range of flu research. (One of these is housed within the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.)

The first day of the CEIRS meeting, Jul 30, will include a discussion of implementation issues for the US policy on oversight of life-sciences dual-use research, according to an agenda supplied by the NIAID. A panel discussion will include the lead authors of the two controversial ferret studies, Ron Fouchier, PhD, of Erasmus University in the Netherlands and Yoshihiro Kawaoka, DVM, PhD, of the University of Wisconsin and the University of Tokyo.

The CEIRS meeting will not be open to the media, according to the NIAID.

According to a National Public Radio (NPR) report today, Adolfo Garcia-Sastre, PhD, of Mt. Sinai School of Medicine, one of the meeting organizers, said the meeting would attract "too many people" if it were opened to the media. "I don't think we can do that," he said.

Garcia-Sastre expressed doubt that the research moratorium would be lifted at the meeting, because the decision is not really up to the flu research community, according to the NPR story. He said researchers are still waiting for more information from the federal government about lab safety requirements and risk-mitigation plans.

See also:

WHO guidance on risk-control measures for research on H5N1 transmission